Skip to content

SpyGlass Discover Retrieval Basket

by Boston Scientific EUDAMED510(k)

Active European Union and United States

510(k) K203322

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK203322 Date26 May 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LQR
FDA applicant
Boston Scientific Corporation
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SpyGlass Discover Retrieval Basket is a biliary stone dislodger, classified as a Class II medical device under FDA regulations (876.5010). It is designed as a retrieval tool to grasp and remove biliary and pancreatic stones, including stone fragments, within the biliary anatomy. Constructed from nitinol, this 4-wire basket maintains structural integrity during repeated use cycles.

This device is supplied as a single-use, non-sterile accessory for use with compatible catheters, such as the SpyGlass Discover Digital Catheter. It is intended for use in endoscopic procedures under fluoroscopic guidance, with available sizes including 2.4Fr x 120cm (Model #4299). The device holds FDA 510(k) clearance and EU MDR authorization, adhering to regulatory standards for biliary intervention tools. Storage and handling follow standard sterile medical device protocols upon preparation for use.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SpyGlass Discover Retrieval Basket primarily used for in clinical procedures?

    The SpyGlass Discover Retrieval Basket is designed specifically to grasp and remove biliary and pancreatic stones, including fragments, within the biliary anatomy during endoscopic procedures. Its nitinol construction allows it to maintain structural integrity during repeated use cycles, making it suitable for dislodging and retrieving stones under fluoroscopic guidance.

  • Is the SpyGlass Discover Retrieval Basket intended for single-use or repeated use, and how does this affect its sterility?

    The SpyGlass Discover Retrieval Basket is supplied as a single-use accessory, meaning it is intended for one-time use per procedure. While it is non-sterile as shipped, it follows standard sterile medical device protocols upon preparation for use, ensuring proper sterilization before clinical application.

  • What sizes and models are available for the SpyGlass Discover Retrieval Basket, and how does this relate to compatibility with other devices?

    The SpyGlass Discover Retrieval Basket is available in a single size: 2.4Fr x 120cm, identified by the model number 4299. This design ensures compatibility with compatible catheters, such as the SpyGlass Discover Digital Catheter, for use in endoscopic biliary interventions.

  • How does the SpyGlass Discover Retrieval Basket adhere to regulatory standards, and what does this mean for clinicians?

    The SpyGlass Discover Retrieval Basket holds FDA 510(k) clearance and EU MDR authorization, confirming it meets regulatory requirements for Class II medical devices under FDA regulation 876.5010. This clearance ensures the device has undergone rigorous evaluation for safety and performance, providing clinicians with confidence in its use for biliary stone retrieval procedures.